With eRA 2017 behind us and the craziness of the last few months of the back-to-back organization now over, it's time to take a step back and look at what we learned at this year's eRA event. This year was my first time at eRA. From the latest IDMP updates to the best tapas dish of the meal and everything in between, there were great discussions all around. For the conversation alone, I must say that it was a couple of days well invested. With 40 keynote and breakout sessions taking place over the course of the two days, there was also plenty to see and learn.
eCTD is taking off in the East
Day one commenced with keynotes from some of EXTEDO's executives, clients, and partners. Martin and Maximillian, EXTEDO's co-CEO, kicked off the event with an energetic introduction to EXTEDO. We then took a more leisurely journey through some of the more significant regulatory changes that are taking place around the world at the moment.
We learned from Pfizer and Rephine Balticum that in both the Far East, China, and Pacific region, as well as in the Eastern Europe countries, eCTD is rapidly gaining momentum. Over the next couple of years, organizations marketing products within these regions will need to be ready to create all their submissions in the eCTD format.
And IDMP is taking over the world
We also heard from Identifica and ASPHALION about some of the reasoning and details behind the forthcoming IDMP standard. In the word of Vada Perkins, “IDMP is not just about standardizing the pharmacovigilance information we capture. It’s about eliminating personal bias when it comes to the interpretation of that data”. As these were the people involved in the writing of the regulations and specifications themselves, it was great to hear first-hand some of the many behind-the-scenes happenings that have taken place during the years the standard has taken to prepare.
People and places
Of all these things, though, the one thing that stood out to me most was the mix of different people that were in attendance. During one break alone, I had the opportunity to talk with a couple of people that had recently implemented eCTD within their own US-based pharma companies. Then a few minutes later, I am talking to one of the regulatory officers from the South African medical products agency about how they handle reviews of eCTD submissions within their own authority.
I can't look back at the event without failing to say a few words about the location and venue. Despite being potentially seen as a glamorous vacation location, Mallorca also turned out to be the perfect conference location too. Flight access was easy, and the hotel was fantastic. I also don't think I have ever been so well-fed at a corporate event before! The event was topped off by an evening at the exclusive Mood Beach and Restaurant - a bar that, over the years, has been visited by many Hollywood celebrities. This was once again a great opportunity to spend time and talk with other visitors and sponsors. In my case, talking with OpenText/Documentum and Veeva about their various eSubmission offerings.
So, all-in-all, an exceptional couple of days. If you weren't able to join this year's eRA event, then don't forget to save space in your diary for next time. I can promise it is worth the investment. I look forward to seeing everyone and more at the next eRA event in 2019!
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